MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2009-02-25 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.
[1004885]
It was reported to boston scientific corporation in 2007 that two enteryx kits were used in a procedure (a male patient). The patient underwent an initial enteryx procedure in 2004 and had a total of 13 injections. 10. 5 total cc's were injected with 10. 0 cc's intramuscularly, 0. 3 cc's submucosally, and 0. 2 cc's transmurally. The patient reports epigastric pain occurring approximately once per month. Patient was re-treated six months later. During this retreatment, a total of 8 injections were performed with a total of 8. 4cc's injected, all intramuscularly. In late 2005, the patient began experiencing intermittent epigastric pain (occurring approximately once per month) of severe intensity. The patient's zantac was increased to 150mg bid. The event is not resolved. In 2007, the event was assessed as possibly related to the device and unrelated to the procedure. The event was initially reported by the patient in 2006 at the 21 month re-treatment follow-up visit.
Patient Sequence No: 1, Text Type: D, B5
[8176270]
Clinical study: the product remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: the product has been removed from the global market in september 2005. Bostons scientific no longer produces the reported product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02401 |
| MDR Report Key | 1324762 |
| Report Source | 02,05,07 |
| Date Received | 2009-02-25 |
| Date of Report | 2008-10-13 |
| Date Mfgr Received | 2008-10-13 |
| Date Added to Maude | 2009-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0040-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERYX PROCEDURE KIT |
| Generic Name | CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES |
| Product Code | LMN |
| Date Received | 2009-02-25 |
| Model Number | M00572600 |
| Catalog Number | 7260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-25 |